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Minimally Invasive Knee Replacement Outcomes (MIKRO) Study

This study has been completed.
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00633113
First received: March 4, 2008
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to evaluate and compare the clinical, radiographic (x-ray) and cost effectiveness outcomes (cost relative to risks and benefits) of two different minimally invasive knee joint replacement surgical techniques. The primary study hypothesis is that in comparing total knee replacement performed with the two different surgical techniques that respect four minimally invasive surgery principles (low-profile instrumentation, "minimally invasive" incision, overall minimal knee surgical intervention), a faster return to function will result when the technique does not incise the tendon.


Condition Intervention
Knee Osteoarthritis
 Procedure: MPPA
Procedure: SV

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Blinded Clinical Trial Comparing Two Total Knee Replacement Techniques

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Primary outcome: clinical outcomes in the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups, using the Knee Society Score. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome: Includes cost-effectiveness of the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups; EQ-5D, SF-12; radiographic assessment using Knee Society Radiographic Assessment. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: November 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
- Medial Parapatellar Arthrotomy (MPPA) technique
 Procedure: MPPA
- Medial Parapatellar Arthrotomy
Active Comparator: 2
- Subvastus (SV) technique
 Procedure: SV
- Subvastus Technique

Detailed Description:

This study does not include financial compensation for treatments involved.

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of severely symptomatic knee osteoarthritis that has failed non- operative treatment
  • Males and non-pregnant females, 35-85 years of age at the time of surgery
  • ASA class 1 or 2
  • Procedure will not require computer navigation
  • Patient/Surgeon has not requested another implant
  • Patient has signed an IRB approved study consent form
  • Patient is able and willing to actively participate in post-operative rehabilitation program
  • Patient understands study requirements
  • Patient is willing to comply with follow-up visits and diary documentations
  • Patient is capable of independent ambulation

Exclusion Criteria:

  • Skeletal immaturity
  • More than 10 degrees of valgus or varus deformity as measured from a weight bearing AP alignment view
  • Patients with bilateral knee osteoarthritis who are considering a simultaneous bilateral procedure
  • Bone or ligament insufficiency that requires the use of augments or stems, or constrained component
  • Daily pre-operative use of narcotic pain medication
  • Prior knee arthroplasty
  • Patient is a prisoner
  • Patient has had prior tibial tubercle osteotomy
  • Patient's surgical knee would require removal of hardware prior to TKA
  • Patient has < 95 degrees flexion pre-operatively
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633113

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Zimmer, Inc.
Investigators
Principal Investigator: Ivan M Tomek, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00633113     History of Changes
Other Study ID Numbers: MIKRO
Study First Received: March 4, 2008
Last Updated: April 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Total Knee Arthroplasty
Minimally Invasive Knee Replacement
Knee Osteoarthritis
Cost effectiveness minimally invasive knee surgery

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013